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Effects of an Individualized Training Program on Severity Markers of Obstructives Sleep Apnea/Hypopnea Syndrome (OSAS)

NCT ID: NCT01256307

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-07-31

Brief Summary

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There are two types of treatments depending on the severity of Obstructive Sleep Apnea/Hypopnea Syndrome (OSAS): - for the treatment of severe (AHI\> 30/h), the standard treatment is Continuous Positive Airway Pressure (CPAP). If it proved effective in reducing excessive daytime sleepiness and associated cardiovascular risk, compliance of patients 4 years of treatment falls below 70%. - Treatment of moderate (AHI between 15 and 30/h), lifestyle measures, the bracing of mandibular advancement and / or possibly the head and neck surgery can be proposed. These treatments include side effects and their effectiveness is very controversial.Il therefore seemed interesting to test the impact of physical activity through a standardized training program to re personal effort on the development and improvement of OSAS patients with a sedentary moderate to severe OSAS (AHI between 15 and 40 / h) The main assumption is that the ESR could eventually delay the initiation of treatment with CPAP in severe OSAS or an alternative therapeutic relevance in the moderate OSAS and severe in patients who can not tolerate conventional treatment(CSF). The main objective of this biomedical research is to evaluate the effects of a program of REE in ambulatory index of hourly apneas / hypopneas (AHI = marker of severity of OSAS) .- objectives specify 2AIR effects of REE on the quality of sleep (TxSLP) and daytime symptoms (EDS objective fatigue) on the one hand and the other on the metabolism (OV, SM, IR) and markers of LCR (inflammation, oxidative stress , endothelial function).

Detailed Description

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Conditions

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Sleep Apnea, Obstructive Exercise Training Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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training group

training and educational program

Group Type EXPERIMENTAL

training and educational program

Intervention Type OTHER

8 weeks

control group

Group Type OTHER

educational program

Intervention Type OTHER

8 weeks

Interventions

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training and educational program

8 weeks

Intervention Type OTHER

educational program

8 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Presence of an OSAS
* Apnea Hypopnea Index between 15 and 45/h
* Sedentary subjects (Voorips Activity questionnaire)
* IMC\<40
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Montpellier University Hospital

Montpellier, , France

Site Status

Countries

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France

References

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Bughin F, Desplan M, Mestejanot C, Picot MC, Roubille F, Jaffuel D, Mercier J, Jaussent I, Dauvilliers Y. Effects of an individualized exercise training program on severity markers of obstructive sleep apnea syndrome: a randomised controlled trial. Sleep Med. 2020 Jun;70:33-42. doi: 10.1016/j.sleep.2020.02.008. Epub 2020 Feb 18.

Reference Type DERIVED
PMID: 32193052 (View on PubMed)

Other Identifiers

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8508

Identifier Type: -

Identifier Source: org_study_id